Medline ® Abstract for Reference 5
of 'Retinal vein occlusion: Treatment'
Sustained benefits from ranibizumab for macular edema following central retinal vein occlusion: twelve-month outcomes of a phase III study.
Campochiaro PA, Brown DM, Awh CC, Lee SY, Gray S, Saroj N, Murahashi WY, Rubio RG
Ophthalmology. 2011 Oct;118(10):2041-9. Epub 2011 Jun 29.
PURPOSE: Assess the 12-month efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema after central retinal vein occlusion (CRVO).
DESIGN: Prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trial.
PARTICIPANTS: We included 392 patients with macular edema after CRVO.
METHODS: Eligible patients were randomized 1:1:1 to receive 6 monthly intraocular injections of 0.3 mg or 0.5 mg of ranibizumab or sham injections. After 6 months, all patients with BCVA≤20/40 or central subfield thickness≥250μm could receive ranibizumab.
MAIN OUTCOME MEASURES: Mean change from baseline best-corrected visual acuity (BCVA) letter score at month 12,additional parameters of visual function, central foveal thickness (CFT), and other anatomic changes were assessed.
RESULTS: Mean (95% confidence interval) change from baseline BCVA letter score at month 12 was 13.9 (11.2-16.5) and 13.9 (11.5-16.4) in the 0.3 mg and 0.5 mg groups, respectively, and 7.3 (4.5-10.0) in the sham/0.5 mg group (P<0.001 for each ranibizumab group vs. sham/0.5 mg). The percentage of patients who gained≥15 letters from baseline BCVA at month 12 was 47.0% and 50.8% in the 0.3 mg and 0.5 mg groups, respectively, and 33.1% in the sham/0.5 mg group. On average, there was a marked reduction in CFT after the first as-needed injection of 0.5 mg ranibizumab in the sham/0.5 mg group to the level of the ranibizumab groups, which was sustained through month 12. No new ocular or nonocular safety events were identified.
CONCLUSIONS: On average, treatment with ranibizumab as needed during months 6 through 11 maintained the visual and anatomic benefits achieved by 6 monthly ranibizumab injections in patients with macular edema after CRVO, with low rates of ocular and nonocular safety events. After sham injections for 6 months, treatment with ranibizumab as needed for 6 months resulted in rapid reduction in CFT in the sham/0.5 mg group to a level similar to that in the 2 ranibizumab treatment groups and an improvement in BCVA, but not to the same level as that in the 2 ranibizumab groups. Intraocular injections of ranibizumab provide an effective treatment for macular edema after CRVO.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
Departments of Ophthalmology and Neuroscience, The Johns Hopkins School of Medicine, Baltimore, MD 21287-9277, USA. firstname.lastname@example.org